Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.11.2016 – 30.11.2016

Опубліковано 06.12.2016 о 00:00


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Lot / batch recall of Radial Fiber, advanced fiber tools GmbH

Medical instruments for use in humans – vascular surgery

PDF261KB

Lot recall of Semislip guidewires, Urotech GmbH

Injections / Infusions / Transfusions / Dialysis – catheters

PDF226KB

Lot recall of diverse sterile medical products, Wright Medical UK Ltd.

Non-active implants – bone surgery

PDF290KB

Lot recall of Bowl with 2 sections, STS Medical Group S.à.r.l. / Sengewald / MSP Schmeiser GmbH

Surgical equipment/ Anaesthesia – surgical equipment

PDF80KB

Urgent field safety notice for DiagnostikSuite, Zimmer MedizinSysteme GmbH

Medical electronics / Electromedical devices – pulmonary function diagnostics

PDF210KB

Lot recall of catheter connection / disconnection sets, Bionic Medizintechnik GmbH

Injections / Infusions / Transfusions / Dialysis – catheters

PDF139KB

Lot / batch recall of PEG-Set with fixation / without fixation / primary, Fuhrmann GmbH

Dressings / Pads – dressings

PDF183KB

Urgent field safey notice for Accu-Chek Connect diabetes management app version 1.2.0, Roche Diabetes Care

Injections / Infusions / Transfusions / Dialysis – infusion technology

PDF99KB

Batch recall of Cellfina System Prep Pack CP1, Merz Pharmaceuticals GmbH

Surgical equipment/ Anaesthesia – surgical equipment

PDF68KB

Urgent field safety notice for Avance CS2 / Avance / Amingo, GE Healthcare

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF143KB

Urgent field safety notice for fabian HFO / evolution, ACUTRONIC Medical Systems AG

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF76KB

Urgent field safety notice for Mobile Digital X-Ray GM60A, Samsung Electronics

Radiological technology – mobile radiological diagnostic facilities

PDF40KB

Lot recall of Drill 1 and 2 / Twist Drill PRO / Starter Set, Straumann GmbH

Medical instruments for use in humans – bone surgery

PDF51KB

Batch recall of D-Dimer Rapid Test D-DIMK20, Diagnostik Nord GmbH

In-vitro diagnostics – haematological, histological and cytological products

PDF225KB

Urgent field safety notice for hemodialysis machines Formula / 2000 / Plus / 2000 Plus / Therapy and Domus, Medtronic GmbH

Injections / Infusions / Transfusions / Dialysis – dialysis technology

PDF595KB

Urgent Field Safey Notice for RayStation 4.0 / 4.5 / 4.7 and 5.0, RaySearch Laboratories

Radiotherapy / Radiation protection – radiotherapy treatment planning systems

PDF307KB

Recall of Acuvance®2 Safety Catheter, Smiths Medical ASD

Injections / Infusions / Transfusions / Dialysis – syringes and cannulas

PDF214KB

Lot recall of WECK Visistat 35W, Teleflex Medical

Medical instruments for use in humans – general instruments

PDF183KB

Recall of CELON ELITE ESG-200 / Model Number WA90001A, OLYMPUS Deutschland GmbH

Medical electronics / Electromedical devices – electrotherapy

PDF183KB

Lot recall of GREATBATCH Medical Offset Reamer Handle (00-7804-080-00), Zimmer Biomet

Medical instruments for use in humans – bone surgery

PDF430KB

Lot / batch recall of Bridge Occlusion Ballon, Spectranetics Corporation

Injections / Infusions / Transfusions / Dialysis – catheters

PDF100KB

Lot / batch recall of Turbo Elite atherectomy catheter / ELCA coronary atherectomy catheter, Spectranetics Corporation

Injections / Infusions / Transfusions / Dialysis – catheters

PDF68KB

Recall of SONNET Mini Battery Pack Cable, MED-EL Elektromedizinische Geräte GmbH

Active implantable medical devices – biostimulators

PDF148KB

Lot recall of ART-1023 Quinn’s Advantage Medium with Hepes, CooperSurgical Inc. / ORIGIO

Physical therapy – others

PDF195KB

Batch recall of Reflection Dead Blow Mallet, Smith & Nephew Inc.

Medical instruments for use in humans – bone surgery

PDF82KB

Urgent field safety notice for Elekta AB / IMPAC Medical Systems Inc.

Radiotherapy / Radiation protection – radiotherapy treatment planning systems

PDF119KB

Urgent field safety notice for IMMULITE 2000 / XPi, Siemens Healthcare Diagnostics Inc.

In-vitro diagnostics – equipment / products for clinical chemistry

PDF27KB

Urgent field safety notice for Double Balloon Catheter / Isofuse Isolation Aspiration Catheter, Delcath Systems Inc.

Injections / Infusions / Transfusions / Dialysis – therapeutic apheresis procedures

PDF326KB

Lot recall of E.MOTION PS PRO MENISCAL COMPONENT F3L 20 mm, Aesculap AG

Non-active implants – bone surgery

PDF498KB

Urgent field safety notice for PEG 20FR Tube, AbbVie

Injections / Infusions / Transfusions / Dialysis – probes

PDF143KB

Urgent field safety notice for FlexLab power cord, Siemens Healthcare Diagnostics Inc.

In-vitro diagnostics – equipment / products for clinical chemistry

PDF122KB

Recall of Modular Neck Hip Prostheses of Modular SMF and Modular REDAPT Revision Femoral Hip Systems, Smith & Nephew Inc.

Non-active implants – bone surgery

PDF96KB

Urgent field safety notice for S5 / C5 Perfusion System, LivaNova / Sorin Group Deutschland GmbH

Surgical equipment/ Anaesthesia – surgical equipment

PDF359KB

Urgent field safety notice for SynchroMed II Implantable Drug Infusion Pump, Medtronic

Active implantable medical devices – drug pumps

PDF53KB

Lot recall of K-Wire(s) sterile packaging, Stryker Orthopaedics / Stryker Trauma GmbH

Non-active implants – bone surgery

PDF252KB

Lot recall of SynReam / Flexible shaft, DePuy Synthes / Synthes GmbH

Medical instruments for use in humans – bone surgery

PDF46KB

Urgent field safety notice for Sara Combilizer, ArjoHuntleigh / Getinge Group

General equipment for medical treatment – ward equipment and equipment for emergency medical services

PDF125KB

Lot recall of LASEREDGE 1.5 mm x 1.7 mm Trapezoid Angled 6 / Box, Valeant Pharmaceuticals International Inc. / Bausch + Lomb OPS B.V.

ophthalmological technology – equipment for ophthalmological therapeutics

PDF275KB

Lot recall of ARROW OnControl, Teleflex Medical

Medical instruments for use in humans – bone surgery

PDF280KB

Urgent field safety notice for Brilliance iCT / iCT SP / Big Bore / 64 / 40 / 16 / 6 / 10 / 16P and Ingenuity CT / Core / Core128, Philips Healthcare

Radiological technology – CT scanners

PDF292KB

Lot / batch recall of NEURO FLAPFIXKIT, KLS Martin Group / Gebrüder Martin GmbH & Co. KG

Non-active implants – bone surgery

PDF204KB

EasySept Hydro Plus Cleaning & disinfecting solution, Bausch & Lomb Incorporated / Valeant Pharmaceuticals International Inc.

ophthalmological technology – contact lenses

PDF141KB

Urgent field safety notice for NIM Standard / Contact Reinforced EMG Endotracheal Tubes, Medtronic

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF253KB

Lot recall of Delivery Sheath Adelante Breezeway 8F & 10F / ARRIVE Braided Transseptal Sheath, Oscor Inc. / Medtronic

Injections / Infusions / Transfusions / Dialysis – catheters

PDF434KB

Lot recall of Homocystein FS, DiaSys Diagnostic Systems GmbH

In-vitro diagnostics – equipment / products for clinical chemistry

PDF117KB

Batch recall of balanSys UNI convex PE inlay x/5, Mathys AG Bettlach

Non-active implants – bone surgery

PDF39KB

Lot recall of Galeo Pro Coronary Guidewire, Concert Medical LLC

Injections / Infusions / Transfusions / Dialysis – catheters

PDF655KB

Urgent field safety notice for Equinoxe, Exactech Ltd. / UK

Non-active implants – bone surgery

PDF158KB

Urgent field safety notice for Devon Light Glove, ArcRoyal

Surgical equipment/ Anaesthesia – surgical equipment

PDF156KB

Urgent field safety notice for Abdominal Aortic & Junctional Tourniquet (AAJT), Compression Works LLC

General equipment for medical treatment – medico-mechanical devices

PDF73KB

Urgent field safety notice for automated external defibrillators cardiolife AED-2100K, NIHON KOHDEN EUROPE GmbH

Medical electronics / Electromedical devices – electrotherapy

PDF316KB

Urgent field safety notice for lntact-PTH (Parathyroid Hormone) ELISA Kit, Biomerica / MDSS GmbH

In-vitro diagnostics – immunological products

PDF162KB

Lot recall of D-Dimer Rapid Tests, Dutch Diagnostics B.V.

In-vitro diagnostics – haematological, histological and cytological products

PDF337KB

Lot recall of Proline D-Dimer Pro rapid test (IVD), SuZhou Sensogen Biotech Co. Ltd. / Alltest / Promeditech GmbH

In-vitro diagnostics – haematological, histological and cytological products

PDF116KB

Urgent field safety notice for PlGF PLUS KRYPTOR QC, BRAHMS GmbH

In-vitro diagnostics – immunological products

PDF408KB

Urgent field safety notice for Endotracheal Tube with Murphy eye size I.D. 7,5 mm and ETT Set with cuffed Murphy ETT ID 7.5 mm, W. Droh GmbH

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF471KB

Urgent field safety notice for Tina-quant HbA1c Gen.2, Roche

In-vitro diagnostics – equipment / products for clinical chemistry

PDF86KB

Lot recall of MicroTrak CMV HA 2000, Trinity Biotech

In-vitro diagnostics – microbiological products

PDF210KB

Lot recall of Universal Electrosurgical Pad, 3M Deutschland GmbH

Medical electronics / Electromedical devices – electrotherapy

PDF61KB

Lot recall of LOTUS Edge Valve System, Boston Scientific International S.A.

Non-active implants – cardiac surgery

PDF188KB

Lot recall of Covidien Clearify Visualization System, Medtronic

Optics / Precision engineering – endoscopes

PDF119KB

Urgent field safety notice for AXIOM Artis, Siemens Healthcare GmbH

Radiological technology – radiological equipment for vascular diagnostics

PDF95KB

Urgent field safety notice for Artis Q, Siemens Healthcare GmbH

Radiological technology – radiological equipment for vascular diagnostics

PDF102KB

Urgent field safety notice for Artis zee, Siemens Healthcare GmbH

Radiological technology – radiological equipment for vascular diagnostics

PDF112KB

Urgent field safety notice for BIOLOX delta, Corin Limited

Non-active implants – bone surgery

PDF264KB

Urgent field safety notice for ProcedurePak trays containing Light Handle Cover (Devon Light Glove), Mölnlycke Health Care

Surgical equipment/ Anaesthesia – surgical equipment

PDF139KB

Recall of Trocar Catheters, Maquet / Getinge

Injections / Infusions / Transfusions / Dialysis – drainages and suction systems

PDF130KB

Urgent field safety notice for Access Ostase Calibrator Kit and Access Ostase QC Kit, Beckman Coulter

In-vitro diagnostics – equipment / products for clinical chemistry

PDF75KB

Urgent field safety notice for Monaco, Elekta AB / IMPAC Medical Systems Inc.

Radiotherapy / Radiation protection – radiotherapy treatment planning systems

PDF46KB

Urgent field safety notice for QuikRead go (instrument) with software 7.1.10, Orion Diagnostica Oy

In-vitro diagnostics – equipment / products for clinical chemistry

PDF425KB

Urgent field safety notice for Nanostim Leadless Cardiac Pacemaker (LCP) / model number S1DLCP, St. Jude Medical

Active implantable medical devices – cardiac pacemakers

PDF303KB

Urgent field safety notice for Parathyroid hormone intact ELISA, IBL International GmbH

In-vitro diagnostics – immunological products

PDF76KB

Urgent field safety notice for ADVIA Centaur / XP / XPT / CP, Siemens Healthcare Diagnostics Inc.

In-vitro diagnostics – immunological products

PDF184KB

Urgent field safety notice for Rebalance Talar, Zimmer Biomet / Biomet UK Ltd.

Medical instruments for use in humans – bone surgery

PDF688KB

Defibrillation electrode SCHILLER DF87C and DF56C, Leonhard Lang GmbH / SCHILLER Médical SAS

Medical electronics / Electromedical devices – electrotherapy

PDF381KB

Batch / lot recall of LMA MAD Nasal Intranasal Mucosal Atomization Device, Teleflex Medical

Physical therapy – inhalation therapy

PDF168KB

Batch / lot recall of LMA Mucosal Atomization Devices, Teleflex Medical

Physical therapy – inhalation therapy

PDF148KB

Lot recall of MicroTrak Syphilis TPHA 100 / 200 / 500, Trinity Biotech

In-vitro diagnostics – microbiological products

PDF253KB

Lot recall of Xpert MRSA / SA BC, Cepheid

In-vitro diagnostics – microbiological products

PDF100KB

 

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